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Regulators in the US, UK and EU are pushing to phase out animal testing in drug development as alternatives like organ-on-chip, organoids and AI models reach maturity and the FDA nears approval of a liver-chip that outperforms animal tests.

What is a key fact in this story? (1)

**FDA** published a five-year road map in April 2025 to reduce animal testing in drug-safety studies, followed by the **NIH** dropping animal-model requirements for many grants, with the **UK** and **EU** launching similar phase-out plans.

What is a key fact in this story? (2)

**Donald Ingber** at Harvard and biotech **Emulate** built a liver-on-a-chip that identified nearly 7 of every 8 drugs later proven toxic in human clinical trials despite passing animal tests; the chip is in final stages of FDA approval and already used by **Moderna** to screen mRNA vaccine compounds in place of primates.

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FDA, NIH, UK and EU Push to Phase Out Animal Drug Tests — SkimNews

By New Scientist · Summarized & edited by Kapil Samant · 2026-09-15

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FDA published a five-year road map in April 2025 to reduce animal testing in drug-safety studies, followed by the NIH dropping animal-model requirements for many grants, with the UK and EU launching similar phase-out plans.
Donald Ingber at Harvard and biotech Emulate built a liver-on-a-chip that identified nearly 7 of every 8 drugs later proven toxic in human clinical trials despite passing animal tests; the chip is in final stages of FDA approval and already used by Moderna to screen mRNA vaccine compounds in place of primates.
Molecular geneticist Hans Clevers at Utrecht University said his team developed an antibody for squamous cell head-and-neck cancer entirely in organoids with no conventional animal testing, and the drug is now in Phase III trials.
Roughly 190 million animals are used in biomedical research worldwide each year, yet more than 90% of experimental drugs deemed safe and effective in animals fail to win regulatory approval because they turn out to be toxic to humans.
American public support has eroded sharply: in 2001 most US adults considered medical testing on animals morally acceptable, but by 2025 fewer than half did, with younger Britons showing the fastest-growing appetite for alternatives.
Toxicologist Ivan Rusyn at Texas A&M attributed the regulatory momentum to a decade-long "perfect storm" of scientific, political and regulatory activity, citing the EU's 2013 cosmetics-testing ban as proof that industry adapts when regulators force the issue.
AI in silico models are flagging potential drug targets and predicting toxicity at record speed, but regulators remain cautious because the systems don't always explain how they reach their decisions.

Why it matters: The 90% animal-to-human failure rate cited by Ingber's team shows current animal screens are not just an ethical liability but a costly filter that lets dangerous drugs slip through while blocking safe ones. With the FDA now finalizing approval of a liver-chip that catches 7 of 8 human-toxic drugs that animals miss, pharmaceutical companies and grant recipients face a near-term decision point on adopting organ-chip, organoid and AI tools that regulators are increasingly willing to accept.